BioMark Technology

• Screening for the acetylated form of an FDA approved drug (called Amantadine) given to patients prior to measurement. This is done via LC MS in body fluids. This acetylation is performed by the enzyme called Spermine/Spermidine N-Acetyl Transferase (SSAT). It has been documented that elevated levels of SSAT are observed in many cancers including lung, breast, prostate, and GI cancers. Clinical trials on patients with cancer, as well as healthy subjects, provided proof of principle. In addition, studies in analysis of SSAT mRNA levels in tissue samples demonstrated elevated level of SSAT in various cancers. (See section under WHY)

• Use of high performance metabolites for tissue specific cancers (see section under – CAN WE DETECT SPECIFIC TYPES OF CANCERS USING METABOLOMICS?)

Metabolomics gives you a precise chemical read out on a person’s state of health since it involves the rapid, high throughput characterization of the small molecule metabolites found in an organism. It gives us the unique opportunity to look at both the genotype and envirotype relationships. And it turns out that most diseases aren’t a result of your DNA which is set at birth. In some cases, it’s just the environment. A classic example is lung cancer. Metabolomics can help differentiate patients who are at high risk or low risk of developing specific cancer. This could have a tremendous impact on how doctors treat their patients. BioMark is leveraging the power of metabolomics to explore better ways of warning patients and offering doctors an early detection solution.

Almost every factor affecting health – from genetics and the microbiome to disease and lifestyle – exerts its influence by altering metabolite levels. By producing the most accurate, comprehensive picture of the metabolome, hence metabolomics provides actionable insights to help make better clinical decisions.

Metabolism refers to life-sustaining biochemical processes that occur within all living organisms. Every organism strives for metabolic homeostasis and constantly produces a variety of metabolites to achieve this biological balance. This biochemical composition is also known as the metabolome.

When an organism’s biological systems are disturbed by disease, genetic mutations or environmental factors, its metabolic profile often changes. This makes metabolites excellent candidates for biomarkers and particularly useful for understanding disease states, toxicities, drug interactions, mechanisms of action and other areas of biology. Nearly every internal and external factor impacting a living organism exerts its influence by subtly altering metabolite levels. Because the metabolome is at the nexus of all these factors, it serves as a surrogate to the phenotype itself.

Not only is the metabolome vitally important, it is also well understood. The pathways within the metabolome have served as the foundation of life sciences research for more than a century and have been extensively explored and mapped.

The enzyme is not the biomarker. The biomarker is the product (metabolite) of the enzymatic reaction. An over-expressed enzyme related to cancer will produce many thousands of times more metabolite, thereby exponentially increasing the signal-to-background-noise ratio. The result is an amplified biomarker that acts like beacon for early detection that no traditional biomarker can match.
BioMark has identified one such enzyme that is over-expressed in most types of cancer cells, therefore giving them the ability to detect many tumors. This enzyme is called spermidine/spermine acetyltransferase (SSAT) and it converts an FDA-approved drug called amantadine into an acetylated form called N-acetylamantadine. N-acetylamantadine is produced in high amounts in cancer cells and is easily detected in urine in a cost-effective manner.

Most non-imaging cancer detection assays available today are validated to detect biomarkers that are over-expressed in cancer cells. A majority of these biomarkers are proteins that have become mutated in cell-signaling pathways or highly expressed on the surface of cancer cells. This approach is powerful, but has its limitations when it comes to detecting cancer at the early stages.

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BioMark’s assay can become the front line in cancer detection. During physical examinations, a patient will take a FDA Approved and safe pill (amantadine) that acts as a smart drug, and after 2-4 hours, submits a urine sample for analysis. If the levels of N-acetylamantadine in the urine are elevated above normal levels, traditional methods are then incorporated to specify the location of the cancer. This approach will save the medical system billions of dollars annually and prevent unnecessary harm to patients caused by otherwise invasive procedures.

BioMark Diagnostics has developed new high powered metabolic signatures to increase tumour specificity for lung with Dr. Wishart’s TMIC group at University of Alberta. The TMIC group along with BioMark are conducting a large retrospective lung cancer study using its customized assay.